PARSIPPANY, N.J., Oct. 5, 2016 /PRNewswire/ -- Interpace Diagnostics Corp. (NASDAQ: IDXG), a company that provides specialized molecular diagnostic tests and pathology services, announced today that the New York State Department of Health has reviewed and approved for marketing ThyGenX™, the Company's NextGen Sequencing oncogene panel for indeterminate thyroid nodules.
The New York State approval of ThyGenX, which determines whether or not specific biomarkers are present, enables Interpace to market both ThyGenX and ThyraMir together in the state. ThyGenX typically precedes the running of ThyraMir, and they typically go hand in hand with 82% of ThyGenX cases warranting reflex to a more sophisticated, micro RNA assessment via ThyraMir.
According to Thyroid Disease Manager, New York State accounts for approximately 5% of the 600,000 Thyroid FNA biopsies performed in the US annually. Of the several states that require special licensure to provide testing to patients who reside in their jurisdiction, New York was the final state to issue approval.
The Company first launched ThyraMIR in New York State, which holds laboratory companies to some of the highest standards, in April 2015. Approval of ThyGenX was originally filed in 2015 after it was transferred to a NextGen Sequencing platform and an important PIK3CA biomarker was added.
Since November 2014 the Company has conducted over 6,000 combination ThyGenX/ThyraMir tests for over 400 physicians and hospitals outside of New York State.
Jack Stover, President and CEO of Interpace Diagnostics, commented, "We are pleased with the New York State acceptance of our data submission for ThyGenX and are prepared to leverage this opportunity right away. The ability to now market our combination test on a national basis represents a significant milestone for our Thyroid franchise and Company overall."
About Thyroid Nodules, ThyGenX and ThyraMIR testing
According to the American Thyroid Association, approximately 15% to 30% of the 525,000 thyroid fine needle aspirations (FNAs) performed on an annual basis in the U.S. are indeterminate for malignancy based on standard cytological evaluation, and thus are candidates for ThyGenX and ThyraMIR.
ThyGenX and ThyraMIR reflex testing yields high predictive value in determining the presence and absence of cancer in thyroid nodules. The combination of both tests can improve risk stratification and surgical decision-making when standard cytopathology does not provide a clear diagnosis for the presence of cancer.
ThyGenX utilizes state-of-the-art next-generation sequencing (NGS) to identify more than 100 genetic alterations associated with papillary and follicular thyroid carcinomas, the two most common forms of thyroid cancer. ThyraMIR is the first microRNA gene expression classifier. MicroRNAs are small, non-coding RNAs that bind to messenger RNA and regulate expression of genes involved in human cancers, including every subtype of thyroid cancer. ThyraMIR measures the expression of 10 microRNAs. Both ThyGenX and ThyraMIR are covered by both Medicare and Commercial insurers.
About Interpace Diagnostics Group, Inc.
Interpace Diagnostics is a company that provides clinically useful molecular diagnostic tests and pathology services for evaluating risk of cancer by leveraging the latest technology in personalized medicine for better patient diagnosis and management. The Company currently has three commercialized molecular tests; PancraGen® for the diagnosis and prognosis of pancreatic cancer from pancreatic cysts; ThyGenX, for the diagnosis of thyroid cancer from thyroid nodules utilizing a next generation sequencing assay and ThyraMIR, for the diagnosis of thyroid cancer from thyroid nodules utilizing a proprietary gene expression assay. Interpace Diagnostics' mission is to provide personalized medicine through molecular diagnostics and innovation to advance patient care based on rigorous science.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, relating to our future financial and operating performance. The company has attempted to identify forward looking statements by terminology including "believes," "estimates," "anticipates," "expects," "plans," "projects," "intends," "potential," "may," "could," "might," "will," "should," "approximately" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are based on current expectations, assumptions and uncertainties involving judgments about, among other things, future economic, competitive and market conditions and future business decisions, all of which are difficult or impossible to predict accurately and many of which are beyond company's control. These statements also involve known and unknown risks, uncertainties and other factors that may cause company's actual results to be materially different from those expressed or implied by any forward-looking statement. Known and unknown risks, uncertainties and other factors include, but are not limited to, our ability to adequately finance the business, the market's acceptance of our molecular diagnostic tests; our ability to secure additional business and generate higher profit margins through sales of our molecular diagnostic tests, in-licensing or other means, projections of future revenues, growth, gross profit and anticipated internal rate of return on investments. Additionally, all forward-looking statements are subject to the risk factors detailed from time to time in the Company's periodic filings with the Securities and Exchange Commission (SEC), including without limitation, the Annual Report on Form 10-K filed with the SEC on March 30, 2016. Because of these and other risks, uncertainties and assumptions, undue reliance should not be placed on these forward-looking statements. In addition, these statements speak only as of the date of this press release and, except as may be required by law, the Company undertakes no obligation to revise or update publicly any forward-looking statements for any reason.
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SOURCE Interpace Diagnostics Corp.